Bowa TissueSeal Plus User manual

EN
Operating Manual

Legend
MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS 5
Legend
A Jaws
A1 Disposable electrode tip
A2 Electrode surfaces
B Handle
B1 Ratchet
B2 Jaws holder
B3 Cable connector
C HF cable

Legend
6 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN

Contents
MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS 7
Contents
Legend..................................................................................................................... 5
Contents .................................................................................................................. 7
1. Using this operating manual.......................................................................... 9
1.1. Validity .................................................................................................. 9
1.2. Icons and labeling ............................................................................... 10
1.2.1. Structure of warning instructions ........................................... 10
1.2.2. Risk levels in the warning instructions................................... 10
1.2.3. Tips ....................................................................................... 10
1.2.4. Other icons and labeling ....................................................... 11
1.2.5. Symbols on packaging .......................................................... 11
2. Safety ............................................................................................................. 12
2.1. Intended use ....................................................................................... 12
2.2. General safety instructions.................................................................. 13
2.2.1. HF device.............................................................................. 14
2.2.2. HF cable................................................................................ 14
2.2.3. Active electrodes................................................................... 15
2.2.4. Repairs and servicing............................................................ 15
2.3. Personal safety instructions ................................................................ 16
2.3.1. Patients with pacemakers ..................................................... 16
3. Functionality.................................................................................................. 17
4. Assembly....................................................................................................... 18
4.1. Assembling the ligation instrument...................................................... 18
5. Operation....................................................................................................... 19
5.1. Before use........................................................................................... 19
5.2. During the operation............................................................................ 20
5.3. Withdrawal .......................................................................................... 22
5.4. After use.............................................................................................. 23
6. Dismantling ................................................................................................... 24
6.1. Dismantling the ligation instrument ..................................................... 24

Contents
8 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN
7. Preparation.................................................................................................... 25
7.1. Soaking ............................................................................................... 27
7.2. Dismantling ......................................................................................... 28
7.2.1. Pretreatment in an ultrasonic bath ........................................ 29
7.3. Manual removal of contamination ....................................................... 30
7.4. Automatic preparation in a CDM ......................................................... 32
7.5. Inspection............................................................................................ 35
7.6. Packing ............................................................................................... 36
7.7. Autoclaving ......................................................................................... 37
7.8. Storage ............................................................................................... 38
7.9. Transport............................................................................................. 39
7.10. Functional test in the operating room .................................................. 39
7.11. Recommended operating supplies...................................................... 39
8. Technical specifications .............................................................................. 40
8.1. TissueSeal .......................................................................................... 40
8.2. TissueSeal PLUS ................................................................................ 40
9. Disposal......................................................................................................... 41
10. System overview........................................................................................... 42
10.1. TissueSeal .......................................................................................... 42
10.2. TissueSeal PLUS ................................................................................ 43

1 Using this operating manual
MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS 9
1. Using this operating manual
This operating manual is part of the device.
BOWA-electronic GmbH & Co. KG assume no liability nor
provide any warranty whatsoever for any damage or
consequential damage arising from non-compliance with this
operating manual.
XRead the operating manual, in particular the safety
instructions (see section 2, page 12 )carefully and
thoroughly before use.
XStore the operating manual in a safe place throughout
the service life of the device.
XKeep the operating manual accessible to operating
room personnel.
XGive the operating manual to each successive owner
and/or user of this device.
XAlways update the operating manual whenever you
receive additional information from the manufacturer.
1.1. Validity
This operating manual applies only to the devices designated
on the title page.

1 Using this operating manual
10 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN
1.2. Icons and labeling
1.2.1. Structure of warning instructions
WARNING
"Risk type, source and consequences there of"
(Personal injury)!
XMeasure for risk prevention.
1.2.2. Risk levels in the warning instructions
Symbol Risk level Probability of
occurrence
Consequences of
non-compliance
DANGER Immediate risk Death or serious
injuries
WARNING Possible risk Death or serious
injuries
CAUTION Possible risk Minor injuries
NOTE Possible risk Property damage
1.2.3. Tips
Tips to make your work easier or supplementary explanatory
information for a procedure.

1 Using this operating manual
MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS 11
1.2.4. Other icons and labeling
Icon/Label Meaning
;Prerequisite for an activity
XActivity with one step
1.
2.
3.
Activity with several steps in a
binding sequence
ªResult of preceding activity
•List (first level)
•List (second level)
Emphasis Emphasis
..., see section xxx,
page xxx
Cross reference
1.2.5. Symbols on packaging
Icon/ Labeling Meaning
Manufacturer
Comply with operating
instruction

2 Safety
12 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN
2. Safety
2.1. Intended use
The ligature instruments are intended to be used to seal
arterial and venous blood vessels and vascular tissue
structures in open surgical procedures in gynecology,
urology, general surgery, and other surgical disciplines with
the aid of an HF current and mechanical pressure.
In addition, the ligature instruments are suitable for
conventional bipolar coagulation.
The ligature instruments are intended to be used with the
bipolar ligation operating mode.
They are intended to be used in connection with the ligation
program of BOWA ARC generators.
Do not use the ligation instruments if, in the opinion of a
experienced physician or according to current professional
literature, such use would cause endangerment of the patient
due, for example, to the general condition of the patient, or if
other contraindications are present.
It is not necessary to use a neutral electrode with bipolar
ligation instruments.

2 Safety
MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS 13
2.2. General safety instructions
The HF device may be used only by trained medical staff.
The surgeon and medical staff must be trained in the
fundamental principles, rules for use and risks of HF surgery
and must be familiar with them.
XRead the operating manual carefully and thoroughly
before using the device!
In connection with your responsibility for the sterility of the
ligation instruments, observe the following when using them:
XClean and sterilize the ligation instrument before using it
for the first time. It is not sterile as delivered. With
TissueSeal, the disposable electrode tips are supplied in
sterile condition.
XClean and sterilize the ligation instrument before each
subsequent use.
XUse only cleaning, disinfection and sterilization methods
that have been adequately validated for the specific
devices and products concerned.
XComply with the validated parameters for each cycle.
XObserve the applicable legal requirements in your
country and the hygiene regulations of the hospital.
In case of cleaning in an ultrasound bath or manual
precleaning, there is a risk of infection due to water spray
and vapors:
XWear a face mask and protective clothing.
Adequate ventilation is recommended.

2 Safety
14 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN
2.2.1. HF device
XUse only approved HF devices and programs (see
section section 8, page 40).
XObserve the operating instructions of the HF device and
the general instructions for electrosurgical operations!
Improper use of HF current can lead to endogenous and
exogenous burns and explosions:
XAvoid direct skin contact with HF cables.
XAvoid contact with flammable gases and liquids.
2.2.2. HF cable
Improper use of HF cables can lead to patient injuries:
XNever lay the HF cable on the patient’s skin.
XConnect the ligation instrument for coagulation before
switching on the HF generator.
XWhen plugging or unplugging the HF cable, always
grasp the connector directly.
XUse only HF cables that are in perfect condition. Never
use a defective HF cable.
The HF cable may cause interference to imagery on
monitors:
XNever route the HF cable alongside a camera cable.
XDo not lay the HF cable in loops.
XConsult the operating manuals of the BOWA HF
generators for additional information on interference with
other devices.

2 Safety
MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS 15
2.2.3. Active electrodes
Defective or worn electrodes can cause burns on patients:
XNever use or repair worn or defective electrode
surfaces. Dispose of them.
Hot electrode surfaces may cause patient injuries:
XMaintain sufficient distance between the tips of the
instrument and sensitive tissue structures, such as the
pancreas or intestine.
XEnsure that hot instruments are not used for
preparation.
Inadvertent activation of the ligation instrument may cause
patient injuries:
XDo not lay the ligation instrument on the patient.
Dirty electrodes may cause a short circuit, thereby resulting
in functional failure of the ligation instrument.
XClean the jaw electrodes regularly with a moist cloth.
2.2.4. Repairs and servicing
Do not repair or service defective devices:
XDiscard or replace defective devices.

2 Safety
16 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN
2.3. Personal safety instructions
Incorrect HF generator configuration settings and limited
visibility can lead to patient injuries:
XSelect the HF generator and the HF cable according to
the requirements of the ligation instrument.
XCarry out operations only with adequate visibility.
XNever use ligation instruments with the AUTOSTART
function.
XUse only the ligation program of Bowa ARC generators
with bipolar ligation current.
XPrepare the tissue to be sealed so it is as free as
possible in order to avoid unintentional clamping.
2.3.1. Patients with pacemakers
Malfunctions or destruction of the pacemaker can endanger
the life of the patient or result in irreversible injuries to the
patient:
XNever perform ambulant operations on patients with
pacemakers.
XIn cases of patients with pacemakers, consult the
cardiologist before carrying out HF surgery.
XSet the demand pacemaker to a fixed frequency.
XEnsure that the pacemaker does not come into contact
with the HF electrode.
XKeep a fully operational defibrillator within reach
XCarry out a postoperative pacemaker check.
Pos: 5 /679-BOWA/ HF-Instrumente/Liga tor "TissueSeal und TissueSeal P lus"/03. Funktion sweise @ 5\mod_12917 18350323_6.doc @ 46097 @ 1

3 Functionality
MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS 17
3. Functionality
In bipolar HF surgery, tissue coagulation is achieved by
applying a high-frequency AC current, which generates heat.
The TissueSeal and TissueSeal PLUS ligation instruments
are invasive surgical instruments for use in laproscopic or
open surgery.
The active electrodes (electrode surfaces) are the non-
insulated areas of the jaws.
The HF current flows from one electrode surface of the
instrument through the biological tissue to the other electrode
surface and produces the desired coagulation in a localized
region.
With this method, sealing of a vessel or tissue segment
carrying blood is achieved by HF current in combination with
supplementary pressure.
The sealed location is hemostatically tight with respect to
systolic blood pressure and permanently closed.
Applies only to vessels up to 7 mm in diameter.
The jaws can be opened and closed by actuating the handle.
A ratchet mechanism in the handle provides reproducible
mechanical pressure on the electrode tips when the handle
is closed.
Pos: 6 /679-BOWA/HF-I nstrumente/Ligator "NightKNIFE"/04. Montage @ 5\mod_1277985 233074_6.doc @ 40636 @ 1

4 Assembly
18 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN
4. Assembly
WARNING
Risk of patient injury from non-sterile ligation
instruments!
XThe ligation instrument is not sterile as delivered. Clean
and sterilize the instrument before using it.
4.1. Assembling the ligation instrument
1. With TissueSeal: plug the disposable electrode tip A1
onto the holder for jaw B2.
2. Connect the HF cable Cto the cable connector B3 and
check that it is attached securely.

5 Operation
MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS 19
5. Operation
5.1. Before use
;The ligation instrument is assembled (see section 4,
page 18) and prepared (see section 7, page 25).
WARNING
Risk of patient injury!
XUse only approved BOWA ARC generators with
ligation capability (see section 8, page 40).
XUse only genuine HF cables.
XUse only suitable products and accessories as
described in the system overview.
XUse only intact, sterilized products.
WARNING
Risk of patient injuries from the combustion or
explosion of flammable liquids and gases!
XCarry out electrosurgical operations only with
insufflation using a non-flammable gas (CO2).
XAvoid contact with flammable gases and liquids, such
skin cleaners, disinfectants and anesthetic gases.

5 Operation
20 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN
1. Connect the HF cable Cto the HF device and switch on
the HF device.
2. Set the output power of the HF device.
3. Perform a thorough visual inspection and functional test
each time before using the ligation instrument (see
section 8, page 40).
5.2. During the operation
WARNING
Risk of patient injury due to incorrect device settings
and limited visibility!
XSet the output power of the HF device to the value
necessary for the operation.
XUse only approved programs (see section 8, page 40).
XCarry out operations only with adequate visibility.
WARNING
Risk of patient injury due to hot electrode surfaces and
vapor emission!
XMaintain sufficient distance between the tips of the
instrument and sensitive tissue structures, such as the
pancreas or intestine.
XEnsure that hot ligation instruments are not used for
preparation.
XDo not lay the ligation instrument on the patient.